Abstract 1333P
Background
The CAPITAL study, an open label, randomized phase III study in Japan, demonstrated carboplatin plus nab-paclitaxel significantly improved overall survival (OS) and progression-free survival (PFS) compared to docetaxel. We conducted this analysis to assess the extent to which dose and schedule modifications of carboplatin and nab-paclitaxel were necessary in elderly patients with squamous non-small cell lung cancer (NSCLC).
Methods
Eligible patients had advanced squamous NSCLC with no prior systemic chemotherapy, were aged ≥70 years, and had an ECOG performance status of 0 or 1. Patients were randomized 1:1 to receive docetaxel 60 mg/m2 (D arm) or carboplatin AUC 6 mg/mL/min plus nab-paclitaxel 100 mg/m2 weekly (nab-PC arm) for each 21-day cycle. The primary endpoint was OS. This trial was registered with the UMIN Clinical Trials Registry (UMIN000019843) and the Japan Registry of Clinical Trials (jRCTs041180110).
Results
Between December 2015 and August 2020, 196 patients were randomly assigned to the two treatment arms (D arm, n = 98; nab-PC arm, n = 98). Detailed efficacy data was presented at 2021 American Society of Clinical Oncology annual meeting (Abstract. 9031). The median number of treatment cycles of carboplatin, nab-paclitaxel, and docetaxel were 4 (range: 1–26), 4 (range: 1–26), and 3 (range: 1–15), respectively. Median relative dose intensity of carboplatin, nab-paclitaxel, and docetaxel was 0.94, 0.72, and 0.92, respectively. In the 2nd cycle, approximately 67% of patients received the planned dose in the nab-PC arm, while only 38.1% of patients received the planned dose in the D arm. In cycle 6, approximately 90% of patients needed dose or schedule modification in both arms. In the nab-PC arm, 42.1% of patients required skipping during the first cycle and most of them thereafter. A dose reduction was observed in 20% of patients in cycle 2 and 34.7% in cycle 4. Only 4.2% of patients required no dose reduction or skipping throughout the 6 cycles.
Conclusions
Although most patients required dose reduction or skipping throughout the treatment period, carboplatin plus nab-paclitaxel showed prolonged OS.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
National Hospital Organization Nagoya Medical Center.
Funding
Taiho Pharmaceutical.
Disclosure
G. Saito: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co., Ltd.; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd.; Financial Interests, Personal, Invited Speaker: AstraZeneca K.K.; Financial Interests, Personal, Invited Speaker: Novartis Pharma K.K.; Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co., Ltd. Y. Kogure: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical; Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical; Financial Interests, Personal, Invited Speaker: Novartis Pharma K.K. S. Atagi: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Lilly Japan; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb Japan; Financial Interests, Personal, Invited Speaker: Hisamitsu Pharmaceutical; Financial Interests, Personal, Invited Speaker: Kyowa Kirin; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Lilly Japan; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb Japan; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Invited Speaker: Novartis Pharma; Financial Interests, Personal, Invited Speaker: Thermo Fisher Scientific; Financial Interests, Institutional, Research Grant: Merck. Y. Takiguchi: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Chugai Pharma; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb Japan; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: MSD Oncology; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Research Grant: Boehringer Ingelheim; Financial Interests, Personal, Research Grant: Lilly; Financial Interests, Personal, Research Grant: Kyowa Kirin; Financial Interests, Personal, Research Grant: Chugai Pharma; Financial Interests, Personal, Research Grant: Daiichi Sankyo; Financial Interests, Personal, Research Grant: MSD Oncology; Financial Interests, Personal, Research Grant: Ono Pharmaceutical; Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Kyowa Hakko Kirin; Financial Interests, Personal, Invited Speaker: Oncolys Biopharma; Financial Interests, Personal, Invited Speaker: Kissei Yakuhin; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical Co.; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb Japan; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Takeda; Non-Financial Interests, Personal, Other, Administrative board member: the Japan Lung Cancer Society; Non-Financial Interests, Personal, Other, Administrative board member: the Japan CT Screening Society; Non-Financial Interests, Personal, Other, Administrative board member: the Japan Society for Respiratory Endoscopy; Non-Financial Interests, Personal, Other, Administrative board member: the Japanese Board of Cancer Therapy; Non-Financial Interests, Personal, Other, Administrative board member: Thoracic Oncology Study Group; Non-Financial Interests, Personal, Other, Administrative board member: North East Japan Study Group; Non-Financial Interests, Personal, Other, Administrative board member: Tokyo Cooperative Oncology Group. H. Saka: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Chugai Pharma; Financial Interests, Institutional, Funding: MSD; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Boston Scientific; Financial Interests, Personal, Speaker’s Bureau: Covidien; Financial Interests, Personal, Speaker’s Bureau: Ono; Financial Interests, Personal, Speaker’s Bureau: Taiho; Financial Interests, Personal, Speaker’s Bureau: Ili Lilly for; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Becton Dickinson; Financial Interests, Personal, Speaker’s Bureau: Amco; Financial Interests, Personal, Speaker’s Bureau: Kyowa Hakko Kirin; Financial Interests, Personal, Speaker’s Bureau: Kyorin; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Novartis Pharma; Financial Interests, Personal, Speaker’s Bureau: Fuji Film Toyama; Financial Interests, Institutional, Funding: Ono; Financial Interests, Institutional, Funding: Ili Lilly; Financial Interests, Institutional, Funding: Bristol Meyers; Financial Interests, Institutional, Funding: Chugai; Financial Interests, Institutional, Funding: Beyer; Financial Interests, Institutional, Funding: Olympus; Financial Interests, Institutional, Funding: Boehringer Ingelheim; Financial Interests, Institutional, Funding: Novartis; Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Institutional, Funding: Takeda; Financial Interests, Institutional, Funding: Otshka; Financial Interests, Institutional, Funding: Harada; Financial Interests, Institutional, Funding: Nobelpharma; Financial Interests, Institutional, Funding: Celgene; Financial Interests, Institutional, Funding: Taisho Toyama. A. Inoue: Financial Interests, Personal, Other, Lecture fee: AstraZeneca; Financial Interests, Personal, Other, Lecture fee: Eli Lilly; Financial Interests, Personal, Other, Lecture fee: Boehringer Ingelheim; Financial Interests, Personal, Other, Lecture fee: Chugai Pharmaceutical; Financial Interests, Personal, Other, Lecture fee: MSD; Financial Interests, Personal, Other, Lecture fee: Daiichi Sankyo. T. Kurata: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Chugai; Financial Interests, Personal, Speaker’s Bureau: Ono; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Ono; Financial Interests, Institutional, Principal Investigator: Eli Lilly; Financial Interests, Institutional, Principal Investigator: Takeda; Financial Interests, Personal, Speaker’s Bureau: Pfizer. T. Yamanaka: Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Taiho; Financial Interests, Personal, Funding: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Ono; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Funding: Astellas; Financial Interests, Personal, Invited Speaker: Gilead Sciences; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Otsuka; Financial Interests, Personal, Invited Speaker: Kyowa Kirin; Financial Interests, Personal, Funding: Takeda; Financial Interests, Personal, Funding: Chugai; Financial Interests, Personal, Funding: Taiho; Financial Interests, Personal, Funding: Ono; Financial Interests, Personal, Funding: Bayer; Financial Interests, Personal, Invited Speaker: Merck Serono; Financial Interests, Personal, Funding: Astellas; Financial Interests, Institutional, Other, Contracted Research: Chugai; Financial Interests, Institutional, Other, Contracted Research: EPS. M. Ando: Financial Interests, Institutional, Research Grant: Kyowa Kirin. T. Shibayama: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca plc; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim GmbH; Financial Interests, Personal, Speaker’s Bureau: Novartis International AG; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd.; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co., Ltd.; Financial Interests, Personal, Invited Speaker: Merck Sharp & Dohme; Financial Interests, Personal, Expert Testimony: Daiichi Sankyo Company, Limited; Financial Interests, Institutional, Research Grant: AstraZeneca plc; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim GmbH; Financial Interests, Institutional, Research Grant: Novartis International AG; Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant: bostonscientific.com; Financial Interests, Institutional, Research Grant: Pfizer Inc.; Financial Interests, Institutional, Research Grant: EP-CRSU Co., Ltd.; Financial Interests, Institutional, Research Grant: Okayama University; Financial Interests, Institutional, Research Grant: National Hospital Organization Nagoya Medical Center; Financial Interests, Institutional, Research Grant: Shimane University; Financial Interests, Institutional, Research Grant: West Japan Oncology Group; Financial Interests, Institutional, Funding: Ono Pharmaceutical Co., Ltd. H. Itani: Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Principal Investigator: Chugai Pharmaceutical. Y. Fujita: Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Chugai Pharma; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical; Financial Interests, Institutional, Funding: Lilly; Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Institutional, Funding: Chugai Pharmaceutical; Financial Interests, Institutional, Funding: Taiho Pharmaceutical. N. Yamamoto: Financial Interests, Personal, Invited Speaker: MSD K.K.; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd.; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co., Ltd.; Financial Interests, Personal, Invited Speaker: Thermo Fisher Scientific; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo Co., Ltd.; Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co., Ltd.; Financial Interests, Personal, Invited Speaker: Takeda Pharmaceutical Co., Ltd.; Financial Interests, Personal, Invited Speaker: Eli Lilly Japan K.K.; Financial Interests, Personal, Invited Speaker: Boehringer-Ingelheim; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: GlaxoSmithKline K.K.; Financial Interests, Personal, Invited Speaker: Nippon Kayaku; Financial Interests, Personal, Invited Speaker: Sanofi K.K.; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Funding: Otsuka Pharmaceutical Co., Ltd.; Financial Interests, Personal And Institutional, Funding: Chugai Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Funding: Shionogi & Co., Ltd.; Financial Interests, Institutional, Funding: Daiichi Sankyo Co., Ltd.; Financial Interests, Institutional, Funding: Taiho Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Funding: Tsumura & Co.; Financial Interests, Institutional, Funding: Eli Lilly Japan K.K.; Financial Interests, Personal and Institutional, Funding: Boehringer-Ingelheim; Financial Interests, Institutional, Funding: Nippon Kayaku; Financial Interests, Institutional, Funding: Asahi Kasei Pharma; Financial Interests, Institutional, Funding: Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Funding: Amgen Inc.; Financial Interests, Personal and Institutional, Funding: Tosoh Life Science Research Laboratory; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Personal, Invited Speaker: Hisamitsu Pharmaceutical Co. Inc.; Financial Interests, Personal, Invited Speaker: Merck Biopharma; Financial Interests, Personal, Invited Speaker: Guardant Health Japan; Financial Interests, Institutional, Advisory Role: AstraZeneca; Financial Interests, Institutional, Advisory Role: MSD K.K.; Financial Interests, Institutional, Advisory Role: Ono Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Advisory Role: Taiho Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Advisory Role: Takeda Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Advisory Role: Chugai Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Advisory Role: Eli Lilly Japan K.K.; Financial Interests, Institutional, Advisory Role: Boehringer-Ingelheim; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: Pfizer Inc.; Financial Interests, Institutional, Advisory Role: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Role: Nippon Kayaku; Financial Interests, Institutional, Advisory Role: Life Technologies Japan Ltd.; Financial Interests, Institutional, Advisory Role: Life Technologies Japan Ltd.; Financial Interests, Institutional, Advisory Role: Amgen Inc.; Financial Interests, Institutional, Advisory Role: Janssen Pharmaceutical K.K. A. Gemma: Financial Interests, Personal, Invited Speaker: Taiho; Financial Interests, Personal, Advisory Role: Nihon Kayaku; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Ono; Financial Interests, Personal, Invited Speaker: Behringer Ingelheim; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Kyowa Kirin; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Daiichi Sankyo. All other authors have declared no conflicts of interest.